Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
aztreonam (UNII: G2B4VE5GH8) (aztreonam - UNII:G2B4VE5GH8)
E.R. Squibb & Sons, L.L.C.
aztreonam
aztreonam 1 g in 50 mL
INTRAVENOUS
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam injection) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AZACTAM is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Pseudomonas aeruginosa , Enterobacter cloacae , Klebsiella oxytoca *, Citrobacter species*, and Serratia marcescens *. Lower Respiratory Tract Infections , including
AZACTAM® (aztreonam injection) in GALAXY plastic container (PL 2040) is supplied as a frozen, 50 mL single-dose intravenous solution as follows: Store at or below –20°C (–4°F) [see Directions for Use of AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) ].
New Drug Application
AZACTAM- AZTREONAM INJECTION, SOLUTION E.R. SQUIBB & SONS, L.L.C. ---------- AZACTAM (AZTREONAM INJECTION) IN GALAXY PLASTIC CONTAINER (PL 2040) FOR INTRAVENOUS USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION AZACTAM (aztreonam injection) contains the active ingredient aztreonam, a monobactam. It was originally isolated from _Chromobacterium violaceum_. It is a synthetic bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo- 3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Structural formula: C H N O S MW 4 35.4 4 AZACTAM in the GALAXY plastic container (PL 2040) is a frozen, iso-osmotic, sterile, sodium-free, nonpyrogenic intravenous solution. Each 50 mL of solution contains 1 g, or 2 g aztreonam with approximately 1.7 g, or 700 mg Dextrose Hydrous, USP added to adjust osmolality, and approximately 780 mg, or 1.6 g of arginine added for pH adjustment, respectively. Thawed solutions have a pH in the range of 4.5 to 7.5. The solution is for intravenous administration following thawing at room temperature or under refrigeration. This GALAXY container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expirati Soma hati kamili